− Anal fissures, hemorrhoids, pruritus and other painful perianal conditions.
− In dentistry, as a surface anesthetic for the gums prior to injection and before deep scaling, fitting of new dentures and other painful orodental manipulations.
− In endoscopy, prior to upper and lower gastrointestinal and airway endoscopic maneuvers.
− In urinary catheterization, cystoscopy and painful gynecological and rectal examination

Ledo® Ointment is absorbed following application tomucous membranes and damaged skin.
Surface anesthesia:
Male adult: 20 gm ointment
Female adult: 5- 10 gm ointment
During cytoscopy : 30 gm ointment
During Endoscopy: 10-20 gm ointment
Lubrication for Endotracheal in tubation: 5 gm ointment applied on the surface of the tube just prior to insertion.

Ledo® ointment should not be used for eyes (not for ophthalmic use).
Lidocaine ointment should be used with caution in patients with traumatized mucosa and/or sepsis in the affected region.
When Lidocaine ointment is used in the mouth or throat area, caution should be taken that the application of a topical anesthetic may impair swallowing and enhance the danger of aspiration.
Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
Hepatic / Renal Dysfunction
Not applicable with medicament for topical application.
Children:
No special precautions for use of LEDO® Ointment in children. In infants below two years, the physician should be consulted.
The Elderly:
No special precautions for use of Ledo® Ointment in the elder.

None reported.
Interference with laboratory tests:
None reported.

No harmful effects have been reported with the use of topical anesthetics containing Lidocaine during pregnancy and lactation.

Not applicable with medicament for topical application.

Ledo® Ointment is safe and well tolerated. Rarely, local allergic reactions might occur.

National Pharmaco-vigilance and Drug Safety Centre info:
Fax: +966-11-205-7662
Toll- free number: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Avoid accidental swallowing of large doses of ointment by children.

LEDO® Ointment contains Lidocaine, a local anesthetic rapidly penetrates into deeper tissues of skin in concentrations effective to stabilize neuronal membranes and prevent both initiation and transmission of nerve impulses.
Clinically, Ledo® Ointment provides effective and rapid relief of local pain and discomfort associated with various painful cutaneous and mucocutaneous disorders, arthralgia , myalgia & and acute musculoskeletal painful conditions . LEDO® Ointment has a very rapid onset of action (3 - 5 minutes) and ·its local anesthetic effect extends for 1 - 1.5 hours. LEDO® Ointment is safe, non greasy, non-staining and non-irritant.

The amount of lidocaine systemically absorbed is directly related to both the duration of application and to the area over which it is applied. It is not known if it is metabolized into the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent to that of lidocaine. The metabolite, 2,6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats.
When applied topically to intact skin, the absorption of lidocaine is very low. Increased absorption is therefore to be expected when applied to mucosa or previously damaged skin.

No available data.

• Proylene glycol.
• Macrogol 400.
• Macrogol 1500.
• Macrogol 4000.
• Butyl hydroxyanisole.
• Butyl hydroxytoluene.

Not applicable.

Do not store above 30 ºC.

Carton containing aluminum tube containing of 20 gm along with a leaflet.

None